Anti-regurgitation and/or anti-gastrooesophageal reflux composition, preparation and uses

ABSTRACT

The invention relates to compositions intended for reducing, ideally for eliminating, regurgitation and/or gastro-oesophageal reflux phenomena affecting a subject. Anti-regurgitation and/or anti-reflux infant formulas and milks intended for feeding newborn babies, infants and young children are more particularly described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 13/993,712, filedJul. 30, 2013, which is the U.S. national stage application ofInternational Patent Application No. PCT/EP2011/073039, filed Dec. 16,2011.

The field of the present invention is that of medicine and humannutrition, and in particular infant nutrition.

The invention relates to compositions intended to reduce, ideally toeliminate, regurgitation and/or gastro-oesophageal reflux (GOR)phenomena affecting a subject, and also to the methods for obtainingthem. Anti-regurgitation and/or anti-gastro-oesophageal reflux infantcompositions, formulas, preparations and milks intended for feedingnewborn babies, infants and young children are more particularlydescribed.

Regurgitations constitute a symptom frequently observed in newbornbabies and infants, resulting from an increase in abdominal pressurerelative to thorax pressure. They often occur after meals or duringeructation phenomena. These regurgitations, which can also affectadults, and differ, in the medical sense of the term, from vomiting,have no effect on the development of the child and are mainly a matterof discomfort.

The mechanism of regurgitations can be explained in the following way:the lower oesophageal sphincter is a circular muscle located in thelower part of the oesophagus. During meals, this muscle relaxes so as tofacilitate the propulsion of the foods ingested (food bolus) into thestomach. The main function of this muscle is to prevent the return ofthe stomach contents towards the oesophagus by virtue of its tonicconstriction.

In infants, this muscle may be immature. It may therefore not alwayssupport and compensate for the pressure exerted by the gastric content.It then has a tendency, during and after meals, to relax and to allow,during regurgitations, small amounts of gastric fluid to come back upinto the pharynx and to the mouth, via the oesophagus.

This phenomenon generally appears from the first weeks of the child'slife. The physiological development factors which contribute to theappearance of these regurgitations disappear, most commonlyspontaneously, when the child reaches the age of 12 to 15 months(Vandenplas Y., Belli D. et al., Current concepts and issues in themanagement of regurgitation of infants: a reappraisal, Acta Pediatr 85:531-534, 1996).

Regurgitations are often a cause of worry for parents who, as a result,do not hesitate to consult a physician. Concerns vary, in children, fromsimple discomfort, caused by the burping, to pain (since the oesophagealwall is irritated, this gives rise to oesophageal burns or even ulcers).This pain causes crying and often makes it complicated for the child tofall asleep.

In certain cases, excessively frequent and/or prolonged reflux may beresponsible for complications defining, irrespective of the age of thesubject affected, a pathological gastro-oesophageal reflux (GOR).

In infants and children in particular, pathological reflux can have moreatypical oesophageal and respiratory consequences: a break in theweight/height curve, recurring rhino-pharyngo-bronchitis, asthma andbronchiolitis, or anaemia.

It is estimated that regurgitations and reflux occur in approximately75% of children under the age of one.

The treatment recommended by the European Society of PaediatricGastroenterology, Hepatology and Nutrition (ESPGHAN) consists of athickening of the food bolus. It has in fact been proven by clinicaltests that an increase in the viscosity of the gastric content cansignificantly reduce the frequency and volume of regurgitations.

Drug therapies (prokinetics, antisecretory agents, etc.) are essentiallyreserved for recalcitrant regurgitations and especially for actualreflux.

Thickeners which have been conventionally used for a very large numberof years, such as precooked and/or pregelatinized starches, carob seedflour or pectins, can be added to infant milk during the preparation ofthe feeding bottle.

Starches, in combination with proteins, caseins in particular, whichflocculate at acidic pH, develop, in the stomach, the desired viscosityof the food bolus, which thus makes it possible to avoid regurgitationsand reflux through a heaviness effect. The milk absorbed, at neutral pHin the feeding bottle, exerts, however, a buffering effect on gastricacidity, which effect is responsible for slowing down the thickeningdesired. The effectiveness of the starches then depends on the abilityof the subject's stomach to acidify its food, i.e. to reduce the pH fromapproximately 7 to approximately 3, as rapidly as possible. In children,the required acidification can need between 30 and 60 minutes or more,during which time the child is not shielded from the regurgitations andreflux against which it is desired to protect it.

Contrary to starches, the effect of which depends on the stomach pH,carob seed flour (also referred to as “carob bean gum”, “native carob”,“standard carob” or “natural carob”) is able to thicken at neutral pH.However, thickening the milk in the feeding bottle has the drawback, notinsignificant for the child, of making the milk difficult to drinkthrough the teat. The thickening of the milk in the feeding bottle canconsequently be responsible for aerophagia problems.

A medicament, which has been known for several decades, and which issold in pharmacies under the name Gelopectose®, is moreover used tothicken the contents of the stomach and the faeces. This medicament,consisting of pectin, microcrystalline cellulose and hydrated colloidalsilica, is in the form of a powder to be poured into a feeding bottle ofvery hot (50 to 60° C.) reconstituted milk. The instructions for use ofthe medicament recommend vigorously shaking the feeding bottle, forapproximately 30 seconds, and then leaving the mixture to stand for afew minutes until a gel and the desired temperature (approximately 37°C.) are obtained.

Although it has been used for several decades, this technique is notsatisfactory. It is in fact lengthy and requires a heating means. Inaddition, the dosage of the powder added (2 level teaspoons (“cuillèresà café”) for 90 ml of water before reconstitution of the milk) is oftenimprecise.

The main drawback encountered with this medicament is the same as thatencountered with the carob seed flour, and is linked to the thickeningof the mixture in the feeding bottle. This thickening is in factresponsible for the formation of lumps which, very frequently, block theteat. Moreover, the texture of the reconstituted product changes overtime and means that the preparation has to be consumed rapidly.

Since the approach previously described, consisting of adding athickener to the feeding bottle of milk, proves to be not verypractical, prethickened infant milks, termed “anti-regurgitation” (AR)milks, have moreover been proposed for several years.

These AR formulations already contain a thickener, chosen from starchesand native carob bean gum, responsible for the viscosity of thereconstituted milk, and make it possible to overcome some of thedrawbacks described above.

Native carob bean gum is a carob which has a low solubility in anaqueous medium of about 20% at a temperature between 10° C. and 45° C.(cf. patent application FR 2 913 857). The expression “solubility in anaqueous medium at a temperature between 10° C. and 45° C.” means that,at a temperature between 10° C. and 45° C., in an aqueous medium, thecarob bean gum produces at least 20% of the viscosity that it would haveproduced if it had been placed in solution at temperatures above 80° C.

Native carob and starches thus do not exhibit, at the reconstitutiontemperature of the milk in the feeding bottle (which is betweenapproximately 30° C. and 50° C.), a satisfactory solubility in anaqueous medium. Since such a solubility is, however, necessary and aprerequisite for any homogeneous increase in viscosity, thickeners whichare at least partially, or even completely, soluble at thereconstitution temperature of the feeding bottle are preferentially usedby anti-regurgitation infant milk manufacturers.

In order to meet this need, ingredients and additives, such as precookedor pregelatinized starches and also “cold-soluble” carobs, a largeproportion of the viscous potential of which is already expressedbetween 30 and 50° C., have been developed.

“Cold-soluble” carob bean gum is a carob which has a solubility in anaqueous medium of greater than 60% at a temperature between 10° C. and45° C. according to the definition given above.

The ability of “cold-soluble” carobs to cause a rapid increase in theviscosity of the liquid milk base makes it, however, complicated and inpractice impossible to apply certain technological treatments, such as aheat treatment (during the pasteurization or sterilization step),homogenization and atomization (spraying) necessary for the productionof food powder, in particular powdered infant milks.

The same is true for precooked or pregelatinized starches, the structureof which is not very resistant to the high shear stresses to which theliquid milk base is subjected during the homogenization and atomizationsteps. The breaking up of the starch structure leads to a considerableor even total loss of the final viscosity of the reconstituted AR milk.

Starches, just like “cold-soluble” carob, can therefore only be added tothe infant milk powder by dry mixing.

A major problem posed by the dry mixing of starch and/or of cold-solublecarob with the conventional constituent ingredients of an infant milkbase concerns, however, the homogeneity of the final product. Therelatively small amounts of carob flour or of precooked and/orpregelatinized starch to be added to the powdered infant milk base andthe differences in physical properties of the two powders to be mixed infact notably complicate the production of a homogeneous final product.

Processes for preparing liquid anti-regurgitation infant milk with a lowdry matter content (between 11% and 15% by weight), involving a “UHT”(Ultra High Temperature) treatment, have moreover been described (see,for example, patent EP 0 611 525 B1 or FR 2 699 370 A1), but are notsuitable for infant milk bases of which the dry matter content (beforedrying) is high, namely greater than 15% by weight, typically greaterthan 20% by weight, in particular greater than 25% or than 35% byweight, essentially because of an excessive viscosity which prevents aheat treatment, homogenization and/or atomization step from beingcorrectly carried out.

In addition to the problems encountered, during the manufacture ofinfant milks, for obtaining a viscosity suitable for consumption of saidmilk by children suffering from regurgitation and/or GOR problems,manufacturers are, moreover, confronted with the need to produce a milkwhich meets the regulatory hygiene standards, the bacteriologicalcriteria of which are strict.

While the pasteurization of AR infant milks which are in a liquid formposes little problem, this is not the case for AR infant milks which arein powder form. Thus, although infant milk powders have a low moisturecontent and a low water activity (Aw), and are packaged under a very lowpartial oxygen pressure, the bacteriological risk is still present andincreased as long as ingredients are added via a dry mixing phasewithout the possibility of subsequent heat treatment.

Although regurgitation and reflux problems have been recognized for along time, no entirely satisfactory anti-reflux and/oranti-regurgitation composition has been proposed to date.

The inventors describe, for the first time, an anti-regurgitation and/oranti-reflux composition (the expressions “anti-gastro-oesophagealreflux” and “anti-reflux” being used without distinction in the presenttext) in powder form, in particular an infant milk, and also effectivemethods for preparing such an infant milk.

SUMMARY OF THE INVENTION

The present invention thus relates to a composition, in particular ananti-regurgitation and/or anti-reflux composition, which is in the formof a powder, in particular a dietary or nutritional composition,preferably a milk, in particular an infant milk, preferably ananti-regurgitation and/or anti-reflux infant milk, comprising i) atleast one weakly esterified pectin, preferably an amidated and weaklyesterified pectin, and ii) at least one thickener and/or one gellingagent chosen, for example, from xanthan gum, carboxymethylcellulose,hydroxypropylcellulose, hydroxymethylcellulose, a carrageenan, analginate, guar gum and carob seed flour, preferably chosen from xanthangum, carboxymethylcellulose, hydroxypropylcellulose,hydroxymethylcellulose, methylcellulose, hydroxypropylmethylcelluloseand guar gum, even more preferably from xanthan gum,carboxymethylcellulose and a mixture of xanthan andcarboxymethylcellulose. This composition may advantageously alsocomprise iii) a highly esterified pectin.

The compositions in powder form according to the invention have theconsiderable and unexpected advantage of being, once reconstituted, i.e.obtained using a defined volume of water, liquid at pH 7, in particularin a feeding bottle, and already sufficiently viscous in the stomach, ata pH between 6 and 3.5, in particular between 5.8 and 5, and typicallybetween 5.5 and 5, so as to significantly reduce or even eliminateregurgitation and/or reflux symptoms.

A particular subject of the invention relates to a drink which isreconstituted, for example a reconstituted milk, in particular an infantmilk, from a composition, preferably from an anti-regurgitation and/oranti-reflux composition, in the form of a powder according to theinvention.

Another particular subject of the invention relates to a liquidconcentrate obtained from such a composition in powder form according tothe invention.

The present invention also relates to a process for obtaining acomposition in powder form, in particular an anti-regurgitation and/oranti-reflux composition in powder form, as described previously, inparticular a pasteurized composition in powder form.

This process comprises the following steps of:

-   a) preparing a liquid base, the dry matter content of which is at    least 20% by weight, by mixing, with stirring, at a temperature of    at least 60° C., the constituent elements of said base,-   b) homogenizing said base obtained at the end of step a) by    fractionation of the constituent elements during a first step i)    carried out at a pressure between 100 and 300 bar and during a    step ii) carried out at a pressure between 10 and 60 bar,-   c) spray-drying the mixture obtained at the end of step b), and-   d) recovering the composition obtained at the end of step c) in    powder form.

The previous process may also comprise a step of applying, to the liquidbase obtained at the end of step a) or at the end of step b), a heattreatment, at a temperature between 60° C. and 110° C., for a period oftime sufficient to pasteurize said base.

The composition according to the invention is preferably a dietary foodfor special medical purposes, in particular an infant milk, preferablyan anti-reflux and/or anti-regurgitation infant milk, and the liquidbase is preferably a liquid base of a dietary food for special medicalpurposes, in particular an infant milk liquid base.

The constituent elements of the composition preferably comprise at leastone weakly esterified pectin, preferably at least one amidated andweakly esterified pectin, and at least one thickener and/or one gellingagent chosen, for example, from xanthan gum, carboxymethylcellulose,hydroxypropylcellulose, hydroxymethylcellulose, a carrageenan, analginate, guar gum and carob seed flour, preferably chosen from xanthangum, carboxymethylcellulose, hydroxypropylcellulose,hydroxymethylcellulose, methylcellulose, hydroxypropylmethylcelluloseand guar gum, even more preferably from xanthan gum,carboxymethylcellulose and a mixture of xanthan andcarboxymethylcellulose. A particularly preferred composition alsocomprises at least one highly esterified pectin.

A particular process according to the invention, for obtaining apasteurized infant milk, comprises the following steps of:

-   a) preparing an infant milk liquid base, the dry matter content of    which is at least 20% by weight, by mixing, with stirring, at a    temperature of at least 60° C., the constituent elements of said    base, said constituent elements comprising at least one amidated and    weakly esterified pectin, xanthan and at least one highly esterified    pectin,-   b) homogenizing the infant milk liquid base obtained at the end of    step a) by fractionation of the constituent elements during a first    step i) carried out at a pressure between 100 and 300 bar and during    a step ii) carried out at a pressure between 10 and 60 bar,-   c) applying, to the infant milk liquid base obtained at the end of    step a) or at the end of step b), a heat treatment at a temperature    between 60° C. and 110° C. for a period of time sufficient to    pasteurize said base,-   d) spray-drying the mixture obtained at the end of step c), and-   e) recovering the infant milk, said infant milk being typically a    pasteurized anti-reflux and/or anti-regurgitation infant milk,    obtained at the end of step d) in powder form.

The composition according to the invention is advantageously acomposition which can be obtained using a process according to thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

The composition according to the invention may be a nutritional ordietary composition, in particular a dietary food for special medicalpurposes (FSMP), for example an infant formula or an infant milk,preferably an anti-reflux and/or anti-regurgitation infant milk. Theinfant milk may be a milk for infants (usable from birth), a follow-onmilk (for babies aged at least six months) or a growing-up milk (forchildren at least one year old).

The composition according to the invention may also be a thickeningpreparation, typically an anti-reflux and/or anti-regurgitationpreparation, intended to be added to a food (for children or adults) orelse a pharmaceutical composition for preventing or treating a subjectshowing regurgitation or gastro-oesophageal reflux symptoms.

Conventionally, the subjects concerned are mammals, typically humanbeings of any age, preferably newborn babies, infants, for examplebabies aged 6 months or less, babies from 6 to 18 months old, or youngchildren (children from 12 months to three years old). The subjectsconcerned may also be children over the age of three, adolescents oradults.

The composition according to the invention, typically theanti-regurgitation and/or anti-reflux composition according to theinvention, is advantageously in the form of a powder to bereconstituted, i.e. to be dissolved in a drink (or in any consumableliquid), typically water or milk, for example cow's milk or goat's milk,before ingestion by the subject exhibiting regurgitation and/or refluxsymptoms or liable to exhibit said symptoms.

One particular subject of the invention relates to a reconstituteddrink, preferably a reconstituted anti-regurgitation and/or anti-refluxdrink, such as a drink at neutral pH, for example a milk reconstitutedfrom a composition according to the invention which is in powder form.

Typically, an anti-regurgitation and/or anti-reflux liquid infant milkaccording to the invention comprises a content of said powdered infantmilk of from 11% to 15% by weight and preferably of 13% by weight.

Another particular subject of the invention relates to a liquidconcentrate (prepared from a composition, preferably ananti-regurgitation and/or anti-reflux composition, in powder formaccording to the invention) which is capable of being diluted,preferably using a liquid, the pH of which is close to neutral.

Typically, an anti-regurgitation and/or anti-reflux milk according tothe invention in the form of a liquid concentrate, prepared from acomposition in powder form according to the invention, comprises acontent (i.e. a percentage of dry matter) of said infant milk of from25% to 50% by weight and preferably of 35% by weight. Such a milk may bediluted so as to obtain liquid infant milk according to the invention,typically an anti-regurgitation and/or anti-reflux infant milk,comprising a content of said powdered infant milk of from 11% to 15% byweight and preferably of 13% by weight.

The concentrated infant milk is advantageously preserved by autoclavesterilization and preferentially by a UHT heat treatment followed byaseptic packaging.

The milks according to the invention may be administered orally orenterally. They are preferentially administered orally, since they have,in addition to their role as a food, essentially the role of preventing,limiting or even suppressing regurgitation and/or reflux symptoms.

The composition in powder form according to the invention in fact hasthe significant advantage of being, once reconstituted, liquid at pH 7and viscous at a pH of between 6 and 3.5. It can therefore be used as ananti-regurgitation and/or anti-reflux composition.

For the purposes of the present invention, the viscosity of the foodbolus is considered to be satisfactory if it makes it possible toreduce, and ideally eliminate, regurgitation and/or reflux symptoms.

The viscosity can be measured with a Brookfield viscometer, with a disc-or cylinder-shaped module and at rotational speeds of between 20 and 100revolutions per minute. It is also possible to measure the flow time ofa constant volume of product through a calibrated orifice.

Advantageously, the diluted or reconstituted compositions according tothe invention have:

-   at a pH between 7.3 and 6.5, a viscosity between 20 and 50    centipoises (i.e. between 20 and 50 mPascal·second⁻¹), for example    between 20 and 45 centipoises, between 20 and 30 centipoises or    between 20 and 40 centipoises, preferably between 20 and 30    centipoises;-   at a pH below 6.5, typically of 6 or below 6, typically between 5.8    and 3.5, in particular between 5.8 and 5 or between 5.5 and 3.5, and    preferably between 5.5 and 5 (for example 5.4, 5.3, 5.2 or 5.1), a    viscosity between 150 and 500 centipoises, for example between 150    and 250, 200 and 300 or 200 and 400, or between 250 and 350,    preferably between 150 and 250 centipoises or between 200 and 250    centipoises.

One particular subject of the invention relates to a composition,preferably an anti-regurgitation and/or anti-reflux composition, inparticular a dietary or nutritional composition, in particular a dietaryfood for special medical purposes (FSMP), for example a milk, preferablyan infant milk, even more preferably an anti-reflux and/oranti-regurgitation infant milk, which is in the form of a powder,comprising at least one weakly esterified pectin, preferably at leastone amidated and weakly esterified pectin, and at least one thickenerand/or one gelling agent chosen, for example, from xanthan gum,carboxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose,methylcellulose, hydroxypropylmethylcellulose, a carrageenan, analginate, guar gum and carob seed flour, preferably from xanthan gum,carboxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose,methylcellulose, hydroxypropylmethylcellulose, guar gum and a mixture oftwo or more, for example three, of said thickeners, even more preferablyfrom xanthan gum, carboxymethylcellulose and a mixture of xanthan andcarboxymethylcellulose.

Mixtures of thickeners which are preferred may be chosen from xanthangum and carboxymethylcellulose, xanthan gum and hydroxypropylcellulose,xanthan gum and guar gum, xanthan gum and hydroxypropylmethylcellulose,xanthan gum and methylcellulose, xanthan gum, guar gum andcarboxymethylcellulose, carboxymethylcellulose and guar gum,carboxymethylcellulose and hydroxypropylmethylcellulose,carboxymethylcellulose and methylcellulose, hydroxymethylcellulose andmethylcellulose, and methylcellulose, guar gum andhydroxymethylcellulose, preferably from xanthan gum andcarboxymethylcellulose, xanthan gum and guar gum, xanthan gum andhydroxypropylcellulose, and xanthan gum, guar gum andcarboxymethylcellulose.

A milk reconstituted from a milk in powder form according to theinvention, typically from an anti-regurgitation and/or anti-reflux milkin powder form according to the invention, has a particularly suitableviscosity from pH 6, and more generally at a pH of between 6 and 5, forexample between 5.8 and 5.5, typically at a pH of 5.2, 5.3, 5.4, 5.5,5.6 and 5.7.

It is therefore easy to drink via the teat of the feeding bottle andmakes it possible for the subject to feed without frustration while atthe same time limiting the risks of aerophagia of said subject. Itdevelops, moreover, more rapidly than the known anti-regurgitation milks(a few minutes (typically between 5 and 10 minutes), preferably 5minutes, compared with approximately 30 to 60 minutes), the desiredviscosity in the stomach so as to limit or even eliminate regurgitationand/or reflux (GOR) symptoms. The pH required for the development of asatisfactory viscosity for the purposes of the invention is thereforesignificantly higher, for the composition according to the invention,than the required pH of approximately 3.5 for the known AR compositions.

The desired optimum viscosity of the anti-regurgitation and/oranti-reflux infant milk according to the invention is preferably lessthan 50 mPa·s-1, measured at a pH close to neutral and at a temperaturebetween 35° C. and 40° C., and greater than 160 mPa·s-1, preferably at200 centipoises, even more preferentially between 200 and 300centipoises, when it is measured at pH=5.5 and at a temperature alsobetween 35° C. and 40° C.

The constituent elements of the compositions according to the inventionconstitute the mixture identified in the context of the presentinvention by the term “base”.

Typically, the constituent elements of the dietary or nutritionalcompositions according to the invention constitute the mixtureidentified in the context of the present invention by the term “dietaryor nutritional composition base” and the constituent elements of theinfant milks constitute the mixture identified in the context of thepresent invention by the expression “infant milk base”.

An anti-regurgitation and/or anti-reflux infant milk according to thepresent invention may comprise any infant milk base known to thoseskilled in the art. Thus, any infant milk base, the nutritionalproperties of which are suitable for the needs of infants and children,including dietary foods for special medical purposes (FSMPs), can beused for preparing an infant milk according to the present invention.

A standard infant milk base comprises carbohydrates, lipids, proteins,minerals, vitamins and, optionally, growth factors. The usualproportions of these various constituents in the milk base areapproximately 55% for the carbohydrates, 25% for the lipids, 15% for theproteins and 5% for the minerals and vitamins together, the percentagesbeing calculated relative to the total weight of dry matter of thedehydrated milk base.

The milk base may also optionally comprise other compounds known tothose skilled in the art, such as compounds for improving the texture ofthe milk, the taste of the milk and/or having a specific nutritional orfunctional interest (nucleotides, probiotics, prebiotics, etc.).

Conventionally, the protein fraction of the infant milk base comprisestwo types of proteins: proteins of animal origin, in particular thosederived from milk (casein and soluble proteins, also known as wheyproteins), and proteins of vegetable origin. The protein fraction can,however, comprise only one of these two types of proteins.

The proteins of animal origin can originate, for example, from cow'smilk, from goat's milk, from human milk, from camel's milk, from buffalomilk, from ass's milk and/or from mare's milk.

The proteins of vegetable origin may originate, for example, from rice,from soybean and/or from pea.

The proteins present in the infant milk base, used in the context of thepresent invention, may be whole or, conversely, totally or partiallyhydrolysed. The hydrolysed proteins preferably have a degree ofhydrolysis of between approximately 5% and approximately 90%, preferablybetween approximately 5% and approximately 50%. The degree of hydrolysiscorresponds to the number of peptide bonds broken by the hydrolysis. Thehigher this number, the greater the hydrolysis.

In one particular embodiment for the purposes of the present invention,the degree of hydrolysis of the hydrolysed proteins is betweenapproximately 20% and approximately 50%, preferably betweenapproximately 20% and approximately 40%.

The protein fraction may also comprise amino acids as a mixture. Theamino acids as a mixture may be natural amino acids, synthetic aminoacids or a mixture of natural amino acids and synthetic amino acids.

The amino acids as a mixture may constitute by themselves the proteinfraction of the anti-regurgitation infant milk according to the presentinvention. They may also be present alongside hydrolysed proteins andoptional nonhydrolysed proteins.

These hydrolysed proteins and/or amino acids as a mixture are moreeasily digested than nonhydrolysed proteins and make it possible toaccelerate gastric emptying. A preferred composition according to theinvention, in particular a preferred anti-regurgitation and/oranti-reflux composition, comprises hydrolysed proteins and/or aminoacids as a mixture.

A particular composition according to the invention, typically aparticular anti-regurgitation and/or anti-reflux composition, comprisesa protein fraction containing a majority of hydrolysed proteins and/orof amino acids as a mixture.

Another particular composition according to the invention, typicallyanother particular anti-regurgitation and/or anti-reflux composition,comprises a protein fraction containing a majority of nonhydrolysedproteins.

The lipids typically capable of being part of the composition of theinfant milk according to the present invention may be chosen, forexample, from milk fat, safflower oil, egg yolk lipids, olive oil,coconut oil, palm oil, soybean oil, sunflower oil, fish oil, oilsderived from algae and/or from fungi, palm olein, medium-chaintriglycerides, and esters of fatty acids chosen, for example, fromarachidonic acid, linoleic acid, palmitic acid, stearic acid,docosahexanoic acid, eicosapentanoic acid, linolenic acid, oleic acid,lauric acid, capric acid, caprylic acid and caproic acid.

The carbohydrates capable of being part of the composition of thepresent infant milk (other than the thickeners described later in thepresent description) can be any sugar known to those skilled in the artto be suitable for human nutrition, typically infant nutrition.Typically, the carbohydrates may be chosen from lactose, maltodextrinsor glucose syrup, sucrose, fructose and glucose.

Examples of mineral salts, of vitamins and of other nutrients optionallypresent in the anti-regurgitation infant milk according to the inventioninclude vitamin A, vitamin B6, vitamin B12, vitamin D, in particularvitamin D3 (cholecalciferol), vitamin E, vitamin K, vitamin C, folicacid, thiamine, inositol, riboflavin, niacin, biotin, pantothenic acid,choline, calcium, phosphorus, iodine, iron, magnesium, copper, zinc,manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum,taurine and L-carnitine.

In addition to the compatibility and stability considerations linked tothe preparation processes described in the context of the presentinvention and to the conditions for storage of a milk according to theinvention, the presence and the specific amounts of mineral salts and ofvitamins optionally present may change slightly according to thepopulation targeted (infants or children aged from 6 to 18 months, forexample).

In the context of the present invention, the terms “pectin” and “pecticsubstance” are used without distinction. Pectic substances are acidicpolysaccharide polymers. They are composed of a main chain consisting of1,4-linked uronic acid monomers between which are inserted rhamnosemolecules via 1,2 and 1,4 linkages responsible for the zig-zag shape ofpectin macromolecules. These complex molecules have branches both at theuronic acids and at the rhamnose via molecules of galactan, rhamnan,etc., type.

There is a large variety of pectins, the origin of which is exclusivelyvegetable. Pectins are present in large amount in the pips and zests ofredcurrants, apples, quinces and citrus fruit.

The “weakly esterified” pectins used in the context of the presentinvention are typically citrus fruit pectins.

The degree of amidation of the “amidated and weakly esterified pectin”,present in the composition according to the invention, is betweenapproximately 5% and approximately 30%, preferably between approximately5% and approximately 20%, more preferentially between approximately 10%and approximately 20%.

Its degree of esterification, typically of methylation, is typicallybetween approximately 20% and approximately 50%, preferentially betweenapproximately 30% and approximately 50% and more preferentially betweenapproximately 30% and approximately 40%.

When the composition according to the invention is an infant milk, thepresence, in this composition, of at least one weakly esterified pectin,preferably of at least one weakly esterified, amidated pectin, makes itpossible to obtain a reconstituted infant milk (reconstituted afterdissolving the powder in water) which has a low viscosity, typically aliquid milk which has a viscosity between 20 and 50 centipoises at a pHclose to neutral.

In the compositions according to the invention, typically in theanti-regurgitation and/or anti-reflux infant milks, the “weaklyesterified pectin” is present at a concentration of betweenapproximately 1% and approximately 10%, preferably between approximately2% and approximately 8%, for example between approximately 3% andapproximately 8%, even more preferably between approximately 3% andapproximately 6%, and is typically 4%.

Advantageously, the concentration, in a composition according to theinvention, of weakly esterified pectin and optionally of highlyesterified pectin will be adapted to the nature and to the amount of theproteins optionally present in the composition.

Advantageously, the concentration, in a composition according to theinvention, of weakly esterified pectin, in particular of amidated andweakly esterified pectin, will be all the higher, the richer saidcomposition is in hydrolysed proteins and, conversely, thisconcentration will be all the lower, the richer said composition is innonhydrolysed proteins.

In one particular composition according to the invention, theconcentration of nonhydrolysed proteins is between approximately 13% and14% and that of weakly esterified pectin is approximately 3%.

In another particular composition according to the invention, theconcentration of amino acids as a mixture is between approximately 13%and 14% and that of weakly esterified pectin is approximately 4%.

The “highly esterified” pectins that can be used in the context of thepresent invention are typically citrus fruit pectins, in particularnonamidated citrus fruit pectins.

The inventors have discovered that such a “highly esterified pectin”,used in combination with at least one “weakly esterified pectin”,preferably with at least one “amidated and weakly esterified pectin”,makes it possible to improve the stability of the anti-regurgitationand/or anti-reflux composition according to the invention (in particularthe stability of the proteins) at an acid pH, i.e. at a pH below 4.

The degree of esterification, typically of methylation, of the “highlyesterified pectin” present in the composition according to the inventionis between approximately 50% and approximately 90%, preferably betweenapproximately 50% and approximately 80%, more preferentially betweenapproximately 60% and approximately 70%.

The stability index of said pectin at pH=4 is between 140-200,preferably between approximately 150 and approximately 190, morepreferentially between approximately 165 and approximately 185. Thisindex is a measurement by sedimentation (between 100 and 200) of theability of the highly esterified pectin to protect nonhydrolysedproteins in an acidic medium.

In the compositions according to the invention, typically in theanti-regurgitation and/or anti-reflux infant milks, the “highlyesterified pectin” is advantageously present at a concentration betweenapproximately 0.1% and approximately 10%, preferably betweenapproximately 0.1% and approximately 8%, more preferentially betweenapproximately 1% and approximately 3%.

Preferably, the concentration of highly esterified pectin, in acomposition according to the invention comprising at least one weaklyesterified pectin, preferably at least one amidated and weaklyesterified pectin, and at least one highly esterified pectin, will beall the higher, the richer said composition is in nonhydrolysedproteins, and, conversely, this concentration will be all the lower, thericher said composition is in hydrolysed proteins and/or amino acids asa mixture.

In one particular composition according to the invention, theconcentration of nonhydrolysed proteins is between approximately 13% and14%, that of weakly esterified pectin, typically that of amidated andweakly esterified pectin, is approximately 3%, and that of highlyesterified pectin is between approximately 3% and 4.5% (typically 4%).

In one particular composition according to the invention, theconcentration of highly hydrolysed proteins is between approximately 13%and 14%, that of weakly esterified pectin, typically that of amidatedand weakly esterified pectin, is approximately 4%, and that of highlyesterified pectin is zero or approximately 1%.

As previously indicated, the composition according to the invention,typically the anti-regurgitation and/or anti-reflux composition,comprises at least one weakly esterified pectin, preferably at least oneamidated and weakly esterified pectin, and at least one thickener and/orone gelling agent chosen, for example, from xanthan gum,carboxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose,methylcellulose, hydroxypropylmethylcellulose, a carrageenan, analginate, guar gum and carob seed flour, preferably from xanthan gum,carboxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose,methylcellulose, hydroxypropylmethylcellulose, guar gum and a mixture oftwo or more, for example three, of said thickeners (such as thoseidentified in the present text), even more preferably from xanthan gumand carboxymethylcellulose.

One particular subject of the invention is a milk, preferably ananti-regurgitation and/or anti-reflux milk according to the invention,comprising, for 100 grams of dry matter, 0.5 to 10 grams, preferablybetween 3 and 8 grams, of pectins (“weakly esterified pectin” and/or“highly esterified pectin”), and from 0.5 to 8 grams, preferably between0.5 and 4 grams, typically between 0.5 and 1.5 grams, of thethickener(s) and/or gelling agent(s) chosen.

Among the thickeners of vegetable origin present in the compositionsaccording to the invention alongside the pectin(s), preferred thickenersand/or gelling agents are advantageously chosen from xanthan gum andcarboxymethylcellulose. A thickener of which the use is particularlypreferred is xanthan gum, also identified, in the context of the presentinvention, as “xanthan”.

Xanthan is a branched polysaccharide which is conventionally used as afood additive under the code E415, obtained from the action of abacterium, Xanthomonas campestris. It consists of a combination of foursubunits: glucose, mannose, glucuronic acid and pyruvic acid.

The inventors have discovered that xanthan is a thickener which isperfectly suitable for use in a composition according to the invention,in particular in an infant milk, in combination with one or two of thepectins previously mentioned (on the one hand, “weakly esterified” and,on the other hand, “highly esterified”). The inventors have inparticular demonstrated that such a combination makes it possible toobtain a composition which has a smooth appearance and is not gelled inan aqueous medium at a pH close to neutral, in particular at the pH ofreconstitution of the feeding bottle of milk, and which has ahomogeneous viscosity, in particular at a pH of 6 or below 6, preferablybetween 5.5 and 3.5, making it possible to limit, and ideally toeliminate, regurgitation and/or reflux symptoms thanks to the rapidobtaining of the desired viscosity.

The inventors have also noted the stabilizing effect, both in an acidicmedium and in a neutral medium, exerted by the xanthan used incombination with one or two of the pectins previously mentioned on thecomposition according to the invention.

The compositions according to the invention may also comprise starch, inparticular precooked or pregelatinized starch, preferably pregelatinizedstarch.

Starch is a mixture of 2 homopolymers, amylose and amylopectin, composedof D-anhydroglucopyranose (AGU) units, which belong to thepolysaccharide family. The AGU units are linked to one another viaα-(1-4) linkages, generally characteristic of storage polysaccharides,and α-(1-6) linkages which are responsible for branches in the structureof the molecule. These two homopolymers, which differ by virtue of theirdegree of branching and their degree of polymerization, are:

-   amylose, slightly branched with short branches, the molecular weight    of which can be between 10,000 and 1,000,000 Daltons. The molecule    is made up of from 600 to 1000 glucose molecules; and-   amylopectin or isoamylose, a branched molecule with long branches    every 24 to 30 glucose units by means of α-(1-6) linkages.

The molecular weight of starch is between 1,000,000 and 100,000,000Daltons, and its level of branching is about 5%. The total chain cancome to between 10,000 and 100,000 glucose units.

The ratio between the amylose and the amylopectin depends on the botanicsource of the starch.

Pregelatinized starch is obtained by heating a suspension in water(starch milk). This suspension is unstable but, when heated, becomesviscous and translucent.

A particular milk, typically an anti-regurgitation and/or anti-refluxinfant milk according to the present invention, the protein base ofwhich consists, for example, of an extensive hydrolysate of animal orvegetable proteins (degree of hydrolysis between 20% and 30%), mayadvantageously comprise:

-   -   between approximately 1% and approximately 10%, preferably        between approximately 1% and approximately 5%, even more        preferentially between approximately 2% and approximately 4%, by        weight percentage, of dry matter of weakly esterified pectin,    -   between approximately 0.1% and approximately 10%, preferably        between approximately 0.1% and approximately 8%, even more        preferentially approximately 1% of weight of dry matter of        highly esterified pectin, and    -   between approximately 0.1% and approximately 2%, preferably        between approximately 0.1% and approximately 1%, even more        preferentially between approximately 0.5% and 0.9% of weight of        dry matter of xanthan, relative to the total dry matter weight        of milk.

Such a milk may also comprise between approximately 0.1% andapproximately 10%, preferably between approximately 0.1% andapproximately 5%, even more preferentially between approximately 0.1%and 2%, as weight percentage, of dry matter of pregelatinized starch.

Such proportions are favourable to increasing the viscosity of the milkunder the conditions previously described.

The infant milk base used in the context of the present invention isconventionally in liquid form and typically comprises a dry mattercontent (dry extract) of approximately 25% to 60% by weight, preferablyof approximately 30% to 50%, of approximately 30% to 40% by weight, orof approximately 25% to 45% by weight, even more preferentially ofapproximately 30% to 40% by weight or approximately 35% to 40% byweight.

The pectins and thickeners and/or gelling agents used in the context ofthe present invention may be in powder form or in the form of an aqueoussolution. For the purposes of the invention, the expressions “aqueousmedium” or “aqueous solution” denote respectively a medium or a solutionwhich at least partially consists of water.

A particular anti-regurgitation and/or anti-reflux milk according to theinvention which is in powder form advantageously comprises at least 94%of dry matter, preferably at least 95% of dry matter, even morepreferably at least 98% of dry matter.

The present invention also relates to a process for obtaining acomposition in powder form, in particular a dietary or nutritionalcomposition as described previously, preferably an infant milk, evenmore preferably an anti-regurgitation and/or anti-reflux infant milk, asdescribed previously.

This process comprises the following steps of:

-   a) preparing a liquid base, the dry matter content of which is at    least 20% by weight, by mixing, with stirring, at a temperature of    at least 60° C., the constituent elements of said base,-   b) homogenizing said base obtained at the end of step a) by    fractionation of the constituent elements during a first step i)    carried out at a pressure between 100 and 300 bar and during a    step ii) carried out at a pressure between 10 and 60 bar,-   c) spray-drying the mixture obtained at the end of step b), and-   d) recovering the composition obtained at the end of step c) in    powder form.

The previous process makes it possible, contrary to the processes knownto date, to simply and effectively prepare, from the constituentelements of a base, typically from an infant milk base which is inliquid form, a composition according to the invention, preferably ananti-regurgitation and/or anti-reflux composition, typically ananti-regurgitation and/or anti-reflux infant milk, which will be driedand converted into a powder. The powder obtained at the end of thisprocess is homogeneous, contrary to the powders obtained by dry mixingpreviously described, and the liquid composition reconstituted from sucha powder has the previously described viscosity properties required forlimiting, ideally suppressing, regurgitation and/or reflux symptoms.

The composition in powder form according to the invention may alsoadvantageously be a pasteurized composition.

For the purposes of the present invention, pasteurization denotes a stepof heat treatment which causes the destruction of the microorganismsconsidered to be pathogenic to the subject for whom the composition isintended, and more generally a decrease in the bacterial flora.

Conventionally, the heat treatment is carried out at a temperaturebetween approximately 60° C. and approximately 110° C. for a period oftime between approximately 15 minutes and a few seconds, for exampleapproximately 25 or 30 seconds. Those skilled in the art are able todetermine the period of time suitable for a given temperature which willmake it possible to obtain the desired pasteurization without destroyingthe composition, its nutrient properties or its anti-regurgitationand/or anti-reflux properties. With regard to the milk in particular, aperson skilled in the art is able to determine the conditions suitablefor preserving the proteins and vitamins.

For milk, in particular infant milk, the maximum total flora toleratedmust not exceed 1000 CFU (Colony-Forming Units) per gram of powder.

Among this flora, Clostridium perfringens, Escherichia coli, Bacilluscereus, Listeria monocytogenes, coagulase-positive staphylococci,salmonellae and enterobacteria (in particular Cronobacter sakazakii) arein particular considered to be pathogenic and should preferably betotally eliminated. The process according to the invention, previouslydescribed, makes it possible to eliminate all the bacteria (inparticular the bacteria previously listed) that are pathogenic tohumans, in particular children.

The process previously described may also advantageously comprise anadditional step of applying, to the liquid base obtained at the end ofstep a) or at the end of step b), a heat treatment at a temperaturebetween 60° C. and 110° C. for a period of time sufficient to pasteurizethe liquid base. This process thus makes it possible to obtain apasteurized composition, typically a pasteurized anti-regurgitationand/or anti-reflux composition, in powder form.

Such a composition does not have the microbiological risks (inparticular with respect to C. sakazakii) observed during the dry mixingof an infant milk base with starch or carob powder.

One particular subject of the present invention thus relates to aprocess for obtaining a pasteurized composition, typically a pasteurizedanti-regurgitation and/or anti-reflux composition, in powder form, inparticular an infant milk or a dietary composition as previouslydescribed, comprising the following steps of:

-   a) preparing a liquid base, the dry matter content of which is at    least 20% by weight, by mixing, with stirring, at a temperature of    at least 60° C., the constituent elements of said infant milk base,-   b) homogenizing the liquid base obtained at the end of step a) by    fractionation of the constituent elements during a first step i)    carried out at a pressure between 100 and 300 bar and during a    step ii) carried out at a pressure between 10 and 60 bar,-   c) applying, to the liquid base obtained at the end of step a) or at    the end of step b), a heat treatment at a temperature between 60° C.    and 110° C. for a period of time sufficient to pasteurize said base,-   d) spray-drying the mixture obtained at the end of step c), and-   e) recovering the pasteurized composition obtained at the end of    step d) in powder form.

Step a) of preparing a liquid base comprises mixing, with stirring, theconstituent components, ingredients or elements of interest, aspreviously described, of said base.

The preparation of a liquid mixture involves the dilution of eachingredient in water.

The ingredients (base of the composition, for example infant milk baseor dietary composition base, and thickener(s)) can be mixed in the formof powders and subsequently placed in solution. They can also be mixedin the form of solutions. It is also possible to envisage adding one ofthe components in powder form to the other component which is insolution. In this case, it is preferable to keep the component insolution stirring during the mixing with the component in powder form inorder to limit, ideally to prevent, the formation of agglomerates duringthe mixing.

Thus, the aqueous nature of the mixture obtained at the end of step a)may originate from the liquid form of the thickeners, from the liquidform of the base used and/or from the addition of water to the mixtureof the products used in powder form.

A stirrer or a mixing unit, for example a mixing pump, a deflocculator,or a mixer equipped with a rotor/stator system, may advantageously beused to dissolve the various ingredients and to facilitate the obtainingof a homogeneous base.

The preferred use of a mixer of suitable shape and size also makes itpossible to avoid the excessive incorporation of air into the liquidbase, in particular the milk base.

Those skilled in the art will, moreover, be able to adapt the rotationalspeeds so as to reduce even further such an excessive incorporation ofair into the liquid base.

Mixing step a) is preferably carried out at a temperature of at least60° C., for example between approximately 60° C. and 90° C. or betweenapproximately 60° C. and 80° C., even more preferentially betweenapproximately 70° C. and 75° C. Typically, the temperature is 75° C.

In one preferred embodiment, the liquid base obtained at the end of stepa) is kept stirring until the application of the homogenizing step, forexample using a device as previously described.

The step of homogenizing the mixed, optionally pasteurized, liquid baseobtained at the end of step a) of the process according to the inventionenables the fractionation of the constituent elements of said base. Thehomogenization comprises two steps of compression intended to reinforcethe stability of this base. The first fractionation step i) ispreferably carried out at a pressure between approximately 100 bar andapproximately 300 bar, the second step ii) preferably being carried outat a pressure between approximately 10 bar and approximately 60 bar.

This step is advantageously carried out on a two-stage homogenizer.

The homogenization pressure of the first stage of said homogenizer isthus typically between approximately 100 bar and approximately 300 bar,preferably between approximately 150 bar and approximately 300 bar, evenmore preferentially between approximately 170 bar and approximately 200bar.

The homogenization pressure of the second stage is typically betweenapproximately 10 bar and approximately 60 bar, preferably betweenapproximately 30 bar and approximately 60 bar, even more preferentiallybetween approximately 30 bar and approximately 40 bar.

The pasteurization step optionally present in the preparation processaccording to the invention provides for the application, to the mixtureobtained at the end of step a) or at the end of the homogenizing step,of a heat treatment between approximately 70° C. and approximately 110°C., preferably between 70° C. and 100° C., between 75° C. and 100° C.,between 75° C. and 95° C., between 80° C. and 95° C. or between 85° C.and 95° C., even more preferentially between 80° C. and 90° C., for aperiod of time sufficient to inactivate and destroy at least themicroorganisms considered to be pathogenic (in particular C. sakazakii).

Typically, the heat treatment of the pasteurization step is applied forat least 2 minutes, and preferably at most 10 minutes, when thetemperature is less than or equal to 80° C., for example between 75° C.and 60° C., and for at least 25 seconds, typically at least one minute,and preferably at most 5 minutes, when the temperature is greater thanor equal to 85° C., for example between 85° C. and 100° C.

The treatment may also be applied for a period of time greater than 2minutes, and preferably less than 10 minutes, when the temperature is75° C., for a period of time between approximately 2 minutes andapproximately 3 minutes when the temperature is 80° C., for a period oftime between approximately 1 minute and approximately 2 minutes when thetemperature is 90° C., for a period of time of approximately 1 minutewhen the temperature is 95° C., and of less than 30 seconds, typicallyless than 25 seconds, when the temperature is 100° C.

The pasteurized or unpasteurized mixture obtained at the end of thehomogenizing step of the process according to the invention isadvantageously spray-dried in order to obtain a composition (preferablyan anti-regurgitation and/or anti-reflux composition) in powder formcomprising, as previously explained, a dry extract of between 85% and99%, preferably a dry extract of at least 94% or of at least 95%, evenmore preferentially of at least 98%.

The pasteurized or unpasteurized mixture obtained at the end of thehomogenizing step of the process according to the invention is typicallyintroduced at the top of a spray tower. The mixture is then “sprayed”(converted into an aerosol or mist) by means of a spray turbine or byinjection at high pressure through one or more nozzles. The dropletsthus formed are carried along and dehydrated by a stream of hot air, thetemperature of which is typically between 160° C. and 240° C.,preferably between 180° C. and 220° C. The droplets are dried to give apowder, before falling onto the lower walls of the apparatus. Thepowder-moist air separation is obtained, for example, by means ofcyclone separators, the use of which is well known to those skilled inthe art.

When it is desired to obtain a powdered composition according to such aprocess, the dehydration in the spray tower should preferably not betotal. The residual moisture present in the powdered composition may,for example, be between 6% and 14% at the bottom of the chamber. Thisresidual moisture allows a limited and controlled agglomeration of theparticles, which results in the formation of granules with a porousstructure.

The dehydration can then be finished off in additional devices of thefluidized-bed dryer type. The powder can then be cooled inside avibro-fluidized bed.

It is also possible to prepare a powdered anti-regurgitation and/oranti-reflux composition according to the invention (typically ananti-regurgitation and/or anti-reflux composition allowing, for example,the reconstitution of a milk having the properties previously described,for example a milk which is liquid at a pH of approximately 7 andviscous at a pH between approximately 6 and approximately 3.5, inparticular at a pH between 5.8 and 5) by dry mixing a base (collected inpowder form at the spray tower outlet) with an ingredient of interest aspreviously described, typically at least one weakly esterified pectin,preferably at least one amidated and weakly esterified pectin, and atleast one thickener and/or one gelling agent chosen, for example, fromxanthan gum, carboxymethylcellulose, hydroxypropylcellulose,hydroxymethylcellulose, methylcellulose, hydroxypropylmethylcellulose, acarrageenan, an alginate, guar gum and carob seed flour, preferably fromxanthan gum, carboxymethylcellulose, hydroxypropylcellulose,hydroxymethylcellulose, methylcellulose, hydroxypropylmethylcellulose,guar gum and a mixture of two or more, for example three, of saidthickeners (such as those identified in the present text), even morepreferably from xanthan gum and carboxymethylcellulose.

Other advantages and applications of the present invention will emergeon reading the examples which follow, which should be considered to bepurely illustrative and nonlimiting.

FIGURE LEGENDS

FIG. 1 represents the change in viscosity of the products (measured incentipoises cP) according to the pH of an infant milk prepared accordingto the present invention and of a hypoallergenic (HA) milk reconstitutedwith the addition of gelopectose. The x-axis of the graph thereforegives the pH values: 6.7 and 3.5, and the y-axis gives the viscosityvalues in centipoises.

FIG. 2 represents the change in viscosity of the products (measured incentipoises cP) according to the pH of the infant milk reconstituted at13% of dry extract. The x-axis of the graph therefore gives the pHvalues: neutral, 5.5 and 3.5, and the y-axis gives the viscosity valuesin centipoises.

EXAMPLES Example 1 Formulation

The formulation of milks intended for feeding infants is most commonlystrictly controlled by legislation which sets composition standards.Depending on the country, there may be differences in assessment owingin particular to local specificities in food diversification practice orelse minor modifications of nutritional optimums resulting from work orstudies carried out locally.

Under these conditions, the present example does not intend to representthe diversity of the thickened milk formulations according to theinvention.

Conventionally, in order to meet the nutritional needs of infants,infant milks comprise approximately 10%-15% of proteins, approximately25% of lipids and approximately 50% to 65% of carbohydrates, and alsominerals, vitamins and, optionally, growth factors. Other ingredients,such as, for example, one or more prebiotics and/or probiotics, maymoreover be added to infant milks.

An example of an anti-regurgitation and/or anti-reflux infant milkcomposition according to the invention is given in Table I below.

TABLE I For 100 g of For 100 ml of powder reconstituted milk, at 13%Proteins g 12.1 1.6 Lipids, of which: g 26.2 3.41 Linoleic acid g 4.50.6 α-linolenic acid mg 450 58.5 Carbohydrates, of g 52.7 6.85 which:Maltodextrins g 46.85 4.0 Lactose g 0 0 Starch g 0.94 0.12 HM pectin g1.0 0.4 LM amidated g 4.0 0.52 pectin Xanthan g 0.7 0.09 Energy kcal495.9 64.5 Minerals, of which: g 4.4 0.57 Sodium mg 230 29.9 Potassiummg 610 79.3 Chlorine mg 340 44.2 Calcium mg 620 80.6 Phosphorus mg 34044.2 Magnesium mg 50 6 Iron mg 6 0.8 Zinc mg 4 0.52 Iodine μg 70 9.10Copper μg 350 45.5 Manganese μg 50 6.5 Selenium μg 10 1.3 Molybdenum μg<45 <5.8 Chromium μg <45 <5.8 Fluorine μg <980 <127 Mixture of vitaminsg 0.3 0.039

Example 2 Process for Manufacturing a Pasteurized Infant Milk in PowderForm Comprising i) an Amidated and Weakly Esterified Pectin and ii)Xanthan

The infant milk base comprising 40% of dry extract is prepared by mixingwater previously heated to 75° C. with the various ingredients of theinfant milk (proteins, amidated and weakly esterified pectins,carbohydrates, xanthan, minerals, vegetable fats, vitamins and growthfactors). The pectins are incorporated into the infant milk base keptstirring in order to obtain complete dissolution thereof. The wholemixture is maintained at 75° C. with stirring in a jacketed tank untilthe homogenizing step. The infant milk base then undergoes double-stagehomogenization at 200/40 bar, i.e. a first homogenizing step is carriedout at a pressure of 200 bar and the second homogenizing step is carriedout at a pressure of 40 bar. The homogenized infant milk base is thenpasteurized by heat treatment at approximately 80° C. for 1 to 2 minutesfor the purpose of eliminating the bacteriological risks, in particularthose linked to Cronobacter sakazakii.

The pasteurized infant milk base then undergoes a spraying step carriedout at a pressure of 160 bar, which makes it possible to obtain dropletswhich have a diameter sufficiently small to be dried with air, thetemperature of which at the inlet into the chamber is 183° C. and thetemperature of which at the outlet of the chamber is 94° C.

The process implemented makes it possible here to obtain a flow rate of1000 and 2000 kg of powder/hour.

The reconstituted liquid milk (ready for consumption) obtained from thisinfant milk powder has a dry extract of approximately 13% in the feedingbottle. The viscosity of this reconstituted milk, measured at 60 rpm(revolutions per minute), at 37° C., is between 25 and 45 cP (S61spindle) at a pH close to neutrality, and between 130 and 225 cP for apH range of from 5.5 to 3.5. The reconstituted liquid milk contains0.52% of pectins and 0.091% of xanthan in the feeding bottle.

Example 3 Process for Manufacturing a Pasteurized Infant Milk in PowderForm Comprising at Least i) One Amidated and Weakly Esterified Pectin,ii) One Highly Esterified Pectin and iii) Xanthan

The infant milk base comprising 35% of dry extract is prepared by mixingwater previously heated to 75° C. with the various ingredients of theinfant milk (proteins, amidated and weakly esterified pectins, highlyesterified pectins, carbohydrates, xanthan, minerals, vegetable fats,vitamins and growth factors). The pectins are incorporated into theinfant milk base kept stirring in order to obtain complete dissolutionthereof. The whole mixture is maintained at 75° C. with stirring in ajacketed tank until the homogenizing step. The infant milk base thenundergoes double-stage homogenization at 200/40 bar, i.e. a firsthomogenizing step is carried out at a pressure of 200 bar and the secondhomogenizing step is carried out at a pressure of 40 bar. Thehomogenized infant milk base is then pasteurized by heat treatment atapproximately 80° C. for 1 to 2 minutes for the purpose of eliminatingthe bacteriological risks, in particular those linked to Cronobactersakazakii.

The pasteurized infant milk base then undergoes a spraying step carriedout at a pressure of 150 bar, which makes it possible to obtain dropletswhich have a diameter sufficiently small to be dried with air, thetemperature of which at the inlet into the chamber is 185° C. and thetemperature of which at the outlet of the chamber is 96° C.

The process implemented makes it possible here to obtain a flow rate of1000 and 2000 kg of powder/hour.

The reconstituted liquid milk (ready for consumption) obtained from thisinfant milk powder has a dry extract of approximately 13% in the feedingbottle. The viscosity of this reconstituted milk, measured at 60 rpm(revolutions per minute), at 37° C., is between 25 and 45 cP (S61spindle) at a pH close to neutrality and between 150 and 250 cP for a pHrange of from 5.8 to 3.5. The infant milk powder obtained contains 5% ofpectins and 0.7% of xanthan. The reconstituted liquid milk in thefeeding bottle therefore contains approximately 0.65% of pectins and0.091% of xanthan.

Example 4 Comparison of the Viscosity of a Reconstituted Milk Accordingto the Invention with the Viscosity of a Milk Thickened by the Additionof Gelopectose®

“Gelopectose®” is an FSMP (Dietary Food for Special Medical Purposes),mainly composed of pectin. The exact composition is the following:pectin (E440), cellulose (E460), silica (E551), maltodextrin, sodiumchloride, calcium chloride, and lemon flavouring.

The exact posology and the exact mode of preparation, given by themanufacturer, are recalled below:

Posology: Use Gelopectose® at the dose of 3% to 5% (i.e. 3 to 5 g for100 ml of water, before reconstitution). For 90 ml of water beforereconstitution, use 2 level teaspoons (“cuillères à café”) ofGelopectose (see posology memo for the number of teaspoons of Gelopectose according to the various volumes of water).

Posology Memo:

-   Water: Gelopectose.-   90 ml: 2 teaspoons (“cuillères à café”).-   120 ml: 2-3 teaspoons (“cuillères à café”).-   150 ml: 3 teaspoons (“cuillères à café”).-   180 ml: 3-4 teaspoons (“cuillères à café”).-   210 ml: 4-5 teaspoons (“cuillères à café”).-   240 ml: 5 teaspoons (“cuillères à café”).-   270 ml: 5-6 teaspoons (“cuillères à café”).-   300 ml: 6 teaspoons (“cuillères à café”).    Mode of Administration:-   Pour the recommended amount of Gelopectose into a feeding bottle of    very hot reconstituted milk (50 to 60° C.). Stir vigorously for    approximately 30 seconds, then leave to stand until the gel and the    desired temperature for administering it to the infant are obtained.-   Above all, do not reshake the feeding bottle after obtaining the    gel.-   Use water with a low mineral content, recommended for preparing    feeding bottles.

The feeding bottle can be stored in a refrigerator (+4° C.) for amaximum of 24 hours; for use, reheat it in a water bath without shakingit.”

The objective of the study is to compare the viscosity of ananti-regurgitation infant milk (comprising a hydrolysate of slightlyhydrolysed serum proteins) prepared according to the present inventionand of a hypoallergenic (HA) infant milk (also comprising a hydrolysateof slightly hydrolysed serum proteins) to which the “Gelopectose®”product has been added.

Method and Tools:

The two products are reconstituted, in a beaker, by mixing with water at37° C. The reconstitution level is 13%, i.e. 13 g of powder in 90 ml ofwater. 300 ml of each solution are prepared.

The HA product is reconstituted first, and then heated to 60° C. asindicated by the manufacturer of Gelopectose®. Six teaspoons (“cuillèresà café”) of Gelopectose® are then added to the 300 ml of milk present inthe feeding bottle.

Vigorous shaking of the feeding bottle is required in order to obtaincorrect dissolution in the feeding bottle and to prevent the formationof lumps. The feeding bottle is then cooled to 37° C.

The anti-regurgitation infant milk according to the invention isreconstituted directly by mixing with water at 37° C.

The viscosities of the two products are then measured using a Brookfieldviscometer (DV-I Prime) at the reconstitution pH (close to neutrality)with an S61 spindle at 60 rpm (revolutions per minute) and at atemperature of 37° C.

Hydrochloric acid, with a molarity equal to 1 (1M HCl) is then added tothe two reconstituted products so as to achieve a pH of 3.5. Theviscosities of the two acidified products are then measured at 37° C.and at a speed of 60 rpm. An S62 spindle was used to measure that of theinfant milk according to the invention and an S61 spindle to measurethat of the HA milk thickened with Gelopectose®. This is because, sincethe infant milk prepared according to the present invention has a highviscosity (cf. results below) at acid pH, it was necessary to change thespindle in order to be able to carry out the measurement.

The measurements obtained appear in Table 2 below.

TABLE 2 Viscosities in cP Invention HA with “Gelopectose ®” pH =approximately 7 44 90 pH = 3.5 225 60Conclusion

The anti-regurgitation infant milk according to the present inventiondemonstrates a much better behaviour, as an anti-regurgitation formula,than the HA formula thickened with the Gelopectose® product.

Indeed, it can be seen that the viscosity of the infant milk preparedaccording to the present invention increases at acid pH, whereas theviscosity of the HA product with Gelopectose® decreases and attains alow viscosity (see FIG. 1).

Furthermore, the infant milk prepared according to the present inventionis simpler and quicker to use since it does not require heating thefeeding bottle to 60° C. and leaving it to cool before giving it to thebaby.

It should be noted, moreover, that this need to heat the reconstitutedinfant milk before adding the Gelopectose leads to a destruction of thevitamins. This destruction is avoided with the infant milk according tothe invention, which simply needs to be diluted, at 37° C., in water.

Finally, the infant milk prepared according to the present inventionshows a low viscosity at a pH close to neutrality, which facilitates thefeeding by the baby, whereas, conversely, the milk thickened withGelopectose® is already very viscous at neutral pH and thereforedifficult for the baby to drink.

Example 5 Comparison of the Viscosity of a Reconstituted Milk Comprisinga Milk in Powder Form According to the Invention Obtained by Dry Mixingwith the Viscosity of a Conventional AR Milk

An infant milk base as described in the “infant base” part of thepresent invention is prepared and collected in powder form at the outletof a spray tower. 4% of amidated and weakly esterified pectin, 1% ofhighly esterified pectin and 0.7% of xanthan are then added to thispowder base by dry mixing.

Method and Tools:

The liquid infant milk is then prepared, by dilution of the infant milkin powder form according to the invention in hot water (at 60° C.) at13% of dry extract. Said liquid infant milk is then cooled to 37° C.

The starch-based conventional AR milk is also prepared by diluting theproduct in water (also at 37° C.) at 13% of dry extract.

The viscosities of the two products are then measured using a Brookfieldviscometer (DV-I Prime) at the reconstitution pH (close to neutrality)with an S61 spindle at 60 rpm (revolutions per minute) and at atemperature of 37° C.

Hydrochloric acid, with a molarity equal to 1 (1M HCl), is added to thetwo reconstituted products so as to achieve a pH of 5.5. The viscositiesof the two acidified products are then measured at 37° C. and at a speedof 60 rpm.

Hydrochloric acid, with a molarity equal to 1 (1M HCl), is then againadded to the two reconstituted products so as to achieve a pH of 3.5.The viscosities of the two acidified products are then again measured at37° C. and at a speed of 60 rpm.

TABLE 3 Viscosities in cP AR Products Neutral pH pH = 5.5 pH = 3.5Conventional AR (native proteins) 10 96 241 Infant milk according to the24 236 234 invention obtained by dry mixing (native proteins)

Example 6 Comparison of the Viscosity of a Milk Reconstituted from aMilk in Powder Form According to the Invention Comprising at Least OneWeakly Esterified Pectin and One of the Thickeners Chosen from Xanthan,Methylcellulose, Carboxymethylcellulose, Hydroxypropylcellulose,Hydroxypropylmethylcellulose and Guar (Compositions 1 to 8) and of MilksReconstituted from Milks in Powder Form Comprising “Native” Carob(Compositions 9 and 10) or “Cold-Soluble” Carob (Composition 11)

The objective of the study is to compare the viscosity ofanti-regurgitation infant milks comprising a hydrolysate of slightlyhydrolysed serum proteins prepared according to the present invention(compositions 1 to 8) and of infant milks also comprising a hydrolysateof slightly hydrolysed serum proteins and “native” carob (compositions 9and 10) or cold-soluble carob (composition 11).

Method and Tools:

The products according to the invention are prepared without dryaddition (compositions 1 to 9). Composition 10 is prepared according toExample 2 of patent application FR 2 913 857. Composition 11 is preparedby drying of an infant milk base and dry addition of 4% of cold-solublecarob.

All the products are reconstituted, in a beaker, by mixing with water at37° C. The level of reconstitution is 13%, i.e. 13 g of powder in 90 mlof water. 300 ml of each solution are prepared.

The viscosities of the products are then measured using a Brookfieldviscometer (DV-I Prime) at the reconstitution pH (close to neutrality)with an S61 spindle (low viscosities) at 60 rpm (revolutions per minute)and at a temperature of 37° C.

Hydrochloric acid, with a molarity equal to 1 (1M HCl), is then added tothe reconstituted products so as to achieve a pH of 3.5. The viscositiesof the acidified products are then measured at 37° C. and at a speed of60 rpm. An S62 spindle (high viscosities) was used to measure that ofthe infant milks of the invention and of composition 11 and an S61spindle (low viscosities) was used to measure that of the milks ofcompositions 9 and 10.

Compositions:

Composition 1 Composition 2 according to according to the invention theinvention For 100 g For 100 g of powder of powder Proteins g 12.1 12.1Lipids, of which: g 26.2 26.2 Linoleic acid g 4.5 4.5 α-Linolenic acidmg 450 450 Carbohydrates, of g 52.7 52.7 which: Maltodextrins g 46.8544.75 Lactose g 0 0 Starch g 0.94 0.94 HM Pectin g 1.00 3.00 LM amidatedpectin g 4.00 4.00 Xanthan g 0.70 Methylcellulose g 0.80 Energy kcal495.90 495.90 Minerals, of which: g 4.4 4.4 Sodium mg 230 230 Potassiummg 610 610 Chlorine mg 340 340 Calcium mg 620 620 Phosphorus mg 340 340Magnesium mg 50 50 Iron mg 6 6 Zinc mg 4 4 Iodine μg 70 70 Copper μg 350350 Manganese μg 50 50 Selenium μg 10 10 Molybdenum μg <45 <45 Chromiumμg <45 <45 Fluorine μg <980 <980 Mixture of vitamins g 0.3 0.3Composition 3 Composition 4 according to according to the invention theinvention For 100 g for For 100 g of powder powder Proteins g 12.1 12.1Lipids, of which: g 26.2 26.2 Linoleic acid g 4.5 4.5 α-Linolenic acidmg 450 450 Carbohydrates, of which: g 52.7 52.7 Maltodextrins g 46.3544.05 Lactose g 0 0 Starch g 0.94 0.94 HM Pectin g 1.0 2.00 LM amidatedpectin g 4.20 4.0 Carboxymethylcellulose g 1.00 Hydroxypropylmethyl- g2.50 cellulose Energy kcal 495.90 495.90 Minerals, of which: g 4.4 4.4Sodium mg 230 230 Potassium mg 610 610 Chlorine mg 340 340 Calcium mg620 620 Phosphorus mg 340 340 Magnesium mg 50 50 Iron mg 6 6 Zinc mg 4 4Iodine μg 70 70 Copper μg 350 350 Manganese μg 50 50 Selenium μg 10 10Molybdenum μg <45 <45 Chromium μg <45 <45 Fluorine μg <980 <980 Mixtureof vitamins g 0.3 0.3 Composition 5 Composition 6 according to accordingto the invention the invention For 100 g For 100 g of powder of powderProteins g 12.1 12.1 Lipids, of which: g 26.2 26.2 Linoleic acid g 4.54.5 α-Linolenic acid mg 450 450 Carbohydrates, of which: g 52.7 52.7Maltodextrins g 44.55 45.05 Lactose g 0 0 Starch g 0.94 0.94 HM Pectin g2.00 2.00 LM amidated pectin g 4.0 4.0 Hydroxypropylcellulose g 2.00Guar g 1.00 Energy kcal 495.90 495.9 Minerals, of which: g 4.4 4.4Sodium mg 230 230 Potassium mg 610 610 Chlorine mg 340 340 Calcium mg620 620 Phosphorus mg 340 340 Magnesium mg 50 50 Iron mg 6 6 Zinc mg 4 4Iodine μg 70 70 Copper μg 350 350 Manganese μg 50 50 Selenium μg 10 10Molybdenum μg <45 <45 Chromium μg <45 <45 Fluorine μg <980 <980 Mixtureof vitamins g 0.3 0.3 Composition 7 Composition 8 according to accordingto the invention the invention For 100 g For 100 g of powder of powderProteins G 12.1 12.1 Lipids, of which: G 26.2 26.2 Linoleic acid G 4.54.5 α-Linolenic acid mg 450 450 Carbohydrates, of g 52.7 52.7 which:Maltodextrins g 44.55 45.05 Lactose g 0 0 Starch g 0.94 0.94 HM Pectin g2.00 LM pectin g 4.0 4.0 Xanthan g 1.00 1.00 Energy kcal 495.90 495.9Minerals, of which: g 4.4 4.4 Sodium mg 230 230 Potassium mg 610 610Chlorine mg 340 340 Calcium mg 620 620 Phosphorus mg 340 340 Magnesiummg 50 50 Iron mg 6 6 Zinc mg 4 4 Iodine μg 70 70 Copper μg 350 350Manganese μg 50 50 Selenium μg 10 10 Molybdenum μg <45 <45 Chromium μg<45 <45 Fluorine μg <980 <980 Mixture of vitamins g 0.3 0.3 Composition10 (according to Example 2 of patent application Composition 9 FR 2 913857) For 100 g For 100 g of powder of powder Proteins g 12.1 12.1Lipids, of which: g 26.2 26.2 Linoleic acid g 4.5 4.5 α-Linolenic acidmg 450 450 Carbohydrates, of which: g 52.7 52.7 Maltodextrins g 44.5546.05 Lactose g 0 0 Starch g 0.94 0.94 HM Pectin g 2.00 LM amidatedpectin g 4.0 Native carob bean gum 1.50 4.00 Energy kcal 495.9 495.9Minerals, of which: g 4.4 4.4 Sodium mg 230 230 Potassium mg 610 610Chlorine mg 340 340 Calcium mg 620 620 Phosphorus mg 340 340 Magnesiummg 50 50 Iron mg 6 6 Zinc mg 4 4 Iodine μg 70 70 Copper μg 350 350Manganese μg 50 50 Selenium μg 10 10 Molybdenum μg <45 <45 Chromium μg<45 <45 Fluorine μg <980 <980 Mixture of vitamins g 0.3 0.3 Composition11 For 100 g of powder Proteins g 12.1 Lipids, of which: g 26.2 Linoleicacid g 4.5 α-Linolenic acid mg 450 Carbohydrates, of which: g 52.7Maltodextrins g 46.05 Lactose g 0 Starch g 0.94 Cold-soluble carob beangum g 4.00 Energy kcal 495.9 Minerals, of which: g 4.4 Sodium mg 230Potassium mg 610 Chlorine mg 340 Calcium mg 620 Phosphorus mg 340Magnesium mg 50 Iron mg 6 Zinc mg 4 Iodine μg 70 Copper μg 350 Manganeseμg 50 Selenium μg 10 Molybdenum μg <45 Chromium μg <45 Fluorine μg <980Mixture of vitamins g 0.3Results:

Viscosities in cP Compositions 1 2 3 4 5 6 7 8 9 10 11 pH = 6.7 44 24 2917 38 40 50 48 60 4 74 pH = 3.5 225 162 195 158 174 155 152 165 17 25200Conclusion:

The anti-regurgitation infant milks according to the present invention(compositions 1 to 8) demonstrate a much better behaviour, as ananti-regurgitation formula, than the products of compositions 9 and 10.The product of composition 11 gives good results, but has the drawbackof having to add cold-soluble carob to the rest of the infant base bydry mixing, such an operation significantly increasing themicrobiological risk.

Thus, it can be seen that the viscosity of the infant milks preparedaccording to the present invention (compositions 1 to 8) increases atacid pH, whereas the viscosity of the products of compositions 9 and 10decreases and the reconstituted products rapidly undergo phaseseparation (cf. viscosities of compositions 9 and 10 at pH 3.5). Thesecompositions are not therefore suitable for use in reducingregurgitations and/or reflux in infants and cannot be used asanti-regurgitation and/or anti-reflux compositions for the purposes ofthe present invention.

We claim:
 1. An anti-reflux and/or anti-regurgitation infant milk in powder form comprising at least one weakly esterified pectin and at least one thickener and/or gelling agent chosen from xanthan gum, carboxymethylcellulose, hydroxypropylcellulose, hydroxymethylcellulose, methylcellulose, hydroxylpropylmethylcellulose or guar gum.
 2. The infant milk according to claim 1, wherein said composition further comprises a protein fraction that contains a majority of hydrolysed proteins and/or of amino acids as a mixture.
 3. The infant milk according to claim 1, wherein said composition comprises at least one highly esterified pectin.
 4. The infant milk according to claim 1, wherein said composition comprises for 100 grams of dry matter, 0.5 to 10 grams of pectin and 0.5 to 4 grams of the chosen thickener.
 5. The infant milk according to claim 4, wherein the chosen thickener is xanthan gum.
 6. An anti-reflux and/or anti-regurgitation infant milk reconstituted from the anti-reflux and/or anti-regurgitation infant milk in powder form according to claim 1, wherein it is liquid at pH 7 and viscous at a pH between 6 and 3.5.
 7. The reconstituted infant milk according to claim 6, wherein the viscosity of said milk, at a pH between 5.5 and 3.5, is between 200 centipoises and 300 centipoises.
 8. An anti-reflux and/or anti-regurgitation infant milk reconstituted from the anti-reflux and/or anti-regurgitation infant milk in powder form according to claim 6, wherein it is liquid at pH 7 and viscous at a pH between 5.8 and
 5. 9. The infant milk according to claim 1, wherein said at least one weakly esterified pectin is an amidated and weakly esterified pectin. 